FDA.reportPublic FDA data

SPF 30 Sunscreen Stick

Manufacturer
OraLabs
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:05

Label at a glance#

ProductSPF 30 Sunscreen Stick
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions). Decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging • To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in t...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10%................Sunscreen

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center immediately.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions). Decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only: Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure • reapply: after 80 minutes

of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun

Protection Measures.Spending time in the sun increases your risk of skin cancer and

early skin aging • To decrease the risk, regularly use a sunscreen with a broad spectrum

SPF of 15 or higher and other sun protection measures including: limit time in the sun,

especially from 10 a.m. -2 p.m. • wear long-sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Paraffin wax, octyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, beeswax, butyloctyl salicylate, fragrance, polyethylene, polycrylene, cetyl alcohol, tocopheryl acetate, ascorbyl palmitate

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Bum SPF 30 Face Stick Master Carton Label
Sun Bum SPF 30 Face Stick Master Carton Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 12810871760003092201F836C-B38B-409C-ABBB-C032E114F5E0-00.jpg
Data codeCode 128C5323T201F836C-B38B-409C-ABBB-C032E114F5E0-00.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-329-01SPF 30 Sunscreen Stick13 g in 1 CONTAINERSTICK131

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63645-32963645-329-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
ETHYLHEXYL PALMITATE2865993309IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 30 Sunscreen StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOraLabs201f836c-b38b-409c-abbb-c032e114f5e02025-12-22WarningsExact identifier
ndc (package): 63645-329-01
ndc (product): 63645-329
ndc11 (package): 63645032901
spl id: 4693163d-3126-e574-e063-6294a90ac85c
spl set id: 201f836c-b38b-409c-abbb-c032e114f5e0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.